A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia

Completed · Phase 3 · Has a placebo group

Conditions studied: Schizophrenia

In brief

A clinical trial to study the efficacy and safety of an investigational drug in acutely psychotic people with schizophrenia. Participants in the study will either receive the drug being studied or a placebo. This study is accepting male and female participants between 18 -65 years old who have been diagnosed with schizophrenia. This study will be conducted in 60 locations world wide. The study will last up to nine (9) weeks.

Key facts

Study ID

NCT04092686

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

464

Starts

2019-10-14

Expected to finish

2023-06-14

Last updated by the study team

2026-06-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female participant between 18 to 65 years of age (inclusive) at the time of consent.
• Participant must give written informed consent and privacy authorization prior to participation in the study.
• Participant meets the Diagnostic and Statistical Manual of Mental Illnesses (DSM-5 )criteria for schizophrenia as established by clinical interview at screeing.
• Participant must have a Clinical Global Impression - Severity (CGI-S) score ≥ 4.
• Participant must have a Positive and Negative Syndrome Scale (PANSS) total score ≥ 80 and a PANSS item score ≥ 4 on 2 or more of the following PANSS items: delusions, conceptual disorganization, hallucinations, and unusual thought content.
• Participant has an acute exacerbation of psychotic symptoms (persisting no longer than 2 months prior to providing informed consent).
• Participant has marked deterioration of functioning in one or more areas.
• Participant is, in the opinion of the Investigator, generally healthy based on screening medical history, physical examination (PE), neurological examination, vital signs, electrocardiogram (ECG) and clinical laboratory values.

You may not qualify if…

• Participant has a DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia. Exclusionary disorders include but are not limited to alcohol use disorder (within past 12 months), substance (other than nicotine or caffeine) use disorder within past 12 months, or lifetime history of significant substance abuse that, in the opinion of the Investigator or Sponsor, may have had a significant and potentially permanent impact on the brain or other body systems, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder, and posttraumatic stress disorder. Symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as these symptoms are not the primary focus of treatment.
• Participant is at significant risk of harming self, others, or objects based on Investigator's judgment.
• Participant has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the participant's ability to complete and/or participate in the study
• Female participant who is pregnant or lactating
• Participant has any clinically significant abnormal laboratory value(s) at Screening as determined by investigator.

Where it is running

• Research Site — Anaheim, California, United States
• Research Site — Bellflower, California, United States
• Research Site — Culver City, California, United States
• Research Site — Long Beach, California, United States
• Research Site — San Diego, California, United States
• Research Site — Sherman Oaks, California, United States
• Research Site — Hollywood, Florida, United States
• Research Site — Miami Springs, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Decatur, Georgia, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Lake Charles, Louisiana, United States
• Research Site — Gaithersburg, Maryland, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Marlton, New Jersey, United States
• Research Site — New York, New York, United States
• Research Site — Richardson, Texas, United States
• Research Site — Burgas, Bulgaria
• Research Site — Kardzhali, Bulgaria
• Research Site — Novi Iskar, Bulgaria
• Research Site — Plovdiv, Bulgaria
• Research Site — Sofia, Bulgaria
• Research Site — Sofia, Bulgaria
• Research Site — Zagreb, Croatia
• Research Site — Rogers, Arkansas, United States

Full record on ClinicalTrials.gov

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